Transcription of 안정성 데이터 평가 - gmpeye.co.kr
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안정성 데이터 평가 - gmpeye.co.kr
ICH Q1E Evaluation for Stability Data GI007A gggmmmpppeeeyyyeee 1 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE (Evaluation for Stability Data) Q1E Current Step 4 version dated 6 February 2003 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. ICH Q1E Evaluation for Stability Data GI007A gggmmmpppeeeyyyeee 2 Q1E Document History First Codification History Date New CodificationNovember 2005 Q1E Approval by the Steering Committee under Step 2 and release for public consultation6 February 2002 Q1E Current Step 4 version Q1E Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.
ICH Q1E Evaluation for Stability Data GI007A ggmmppeeyyee www.gmpeye.co.kr 5 EVALUATION FOR STABILITY DATA 1. 서론(INTRODUCTION) …
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